The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:
250°F/121°C, 30 minutes Gravity
270°F/132°C, 10 minutes Dynamic Air Removal
270°F/132°C, 4 minutes Dynamic Air Removal
270°F/132°C, 15 minutes Gravity
273°F/134°C, 3 minutes Dynamic Air Removal
273°F/134°C, 4 minutes Dynamic Air Removal
275°F/135°C, 3 minutes Dynamic Air Removal
275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal IUSS
270°F/132°C, 3 minutes Gravity IUSS
270°F/132°C, 10 minutes Gravity IUSS
275°F/135°C, 3 minutes Dynamic Air Removal IUSS
275°F/135°C, 3 minutes Gravity IUSS
275°F/135°C, 10 minutes Gravity IUSS

Stated values (as determined in a steam resistometer):

30 minutes at 121°C
9.1 minutes at 128°C
3.3 minutes at 132°C
2.4 minutes at 134°C
1.5 minutes at 135°C

Device Description

The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014.

It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.

AI/ML Overview

The information provided describes the acceptance criteria and study proving the Getinge Assured MI Steam Migrating Integrator meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Test	Pre-Determined Acceptance Criteria	Reported Device Performance
Steam Resistometer (BIER vessel) Testing: (According to ANSI/AAMI/ISO 11140-1:2014 and FDA Guidance)	- Pass result at the stated value (SV) for each temperature claimed: - 30 Minutes at 121°C - 3.8 minutes at 132°C, 4.1 minutes at 132°C, 4.0 minutes at 132°C - 2.1 minutes at 134°C, 2.2 minutes at 134°C, 2.4 minutes at 134°C - 1.7 minutes at 135°C, 2.0 minutes at 135°C, 1.8 minutes at 135°C	PASS
	- Failing Result at 15% less time of SV for each temperature claimed	PASS
	- Failing Result at 1°C less for each temperature claimed	PASS
Hospital Steam Sterilizer Testing: (To demonstrate pass/fail results from an actual sterilization cycle used in a health care facility according to FDA Guidance)	- 100% samples passing under passing conditions for each cycle	PASS
	- 100% samples failing under failing conditions for each cycle	PASS
Dry Heat Testing: (According to ANSI/AAMI/ISO 11140-1:2014 and FDA Guidance)	- Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C)	PASS
Side-by-side testing of the biological indicator and integrator in steam resistometer: (As specified in FDA Guidance)	- The integrator does not reach its endpoint before the biological indicator is inactivated	PASS
Offset/Transference: (According to ANSI/AAMI/ISO 11140-1:2014)	- The indicator agent shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed	PASS

2. Sample size used for the test set and the data provenance:

The study involved "3 manufactured lots" of the Integrator for performance testing. The document does not specify the exact number of units or individual indicators tested within each lot for each distinct test. The data provenance is not explicitly stated as originating from a specific country, but the submission is to the U.S. FDA by a U.S.-based company (SteriTec Products Manufacturing CO INC, 74 Inverness Drive East Englewood, CO 80112 U.S.). The studies are prospective in nature, as they involve active testing of the device to verify performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of device (chemical integrator for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The performance is based on physical and chemical reactions (e.g., color change, migration) under controlled conditions, compared against established standards. Therefore, information about the number or qualifications of human experts establishing ground truth for the test set is not applicable and not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The "ground truth" for chemical indicators like this is determined by objective physical/chemical changes against defined parameters (temperature, time, steam presence). It does not involve subjective human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a passive chemical indicator, not an algorithm or software. Its performance is inherent in its physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for this device's performance is established by objective criteria based on physical and chemical reactions under controlled steam sterilization conditions, defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and FDA guidance. This includes:

Temperature and time exposure in a steam resistometer (BIER vessel).
Observation of indicator agent migration/color change.
Confirmation of lack of reaction under sub-lethal conditions (e.g., 15% less time, 1°C less, dry heat).
Comparison with biological indicators in terms of inactivation.

8. The sample size for the training set:

Not applicable. This is a physical/chemical device, not a machine learning model, so there is no concept of a "training set" in the context of AI.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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October 15, 2024

SteriTec Products Mfg. (a Getinge Group Company) % Barb Smith Principal Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K242795

Trade/Device Name: Getinge Assured MI Steam Migrating Integrator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 16, 2024 Received: September 16, 2024

Dear Barb Smith:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the text "Stephen A. Anisko -S" in a simple, sans-serif font. The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black against a white background, and the letter "S" is slightly offset to the right.

Digitally signed by Stephen A. Anisko -S Date: 2024.10.15 15:28:23 -04'00'

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242795

Device Name Getinge Assured MI Steam Migrating Integrator

Indications for Use (Describe)

273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic Air Removal IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS

Stated values (as determined in a steam resistometer):

30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795

Page 1 of 6

510(k) Summary K242795

Date Prepared: October 15, 2024

Applicant Information

SteriTec Products Manufacturing CO INC (a Getinge Group company) 74 Inverness Drive East Englewood, CO 80112 U.S. Ph: 303-660-4201

Contact: Barb Smith Principal Regulatory Affairs Specialist Ph: 585-370-6101 e-mail: barb.smith@getinge.com

1. Device Name

Trade Name:	Getinge Assured MI Steam Migrating Integrator
Device Classification:	Class II
Common/Usual Name:	Indicator, physical/chemical sterilization process
Classification Name:	Indicator, physical/chemical sterilization process (21 CFR 880.2800, JOJ)

1. Predicate Device
  Getinge Assured MI Steam Migrating Integrator (K200252). SteriTec Products, Manufacturing Co. Inc.

3. Description of Device

It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dve. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.

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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795

Page 2 of 6

4. Intended Use/Indications for Use:

Steam Sterilization Cycles:

250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal 273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS):

270°F/132°C, 4 minutes Dynamic Air Removal IUSS

270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS

275°F/135°C, 3 minutes Dynamic Air Removal IUSS

275°F/135°C, 3 minutes Gravity IUSS

275°F/135°C, 10 minutes Gravity IUSS

Stated values (as determined in a steam resistometer):

30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C

The intended use of the subject device has only been modified with the addition of sterilization cycles, from the referenced predicate device. The monitoring of the following cycles has been added:

10 minutes at 132°C Dynamic Air Removal .
3 minutes at 134°C Dynamic Air Removal .
4 minutes at 134°C Dynamic Air Removal. .

5. Technological Characteristics

The chart below compares the technological characteristics of the subject device, to that of the predicate device:

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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795

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Feature	Predicate Device (K200252)	Modified/Subject Device (K242795)	Comparison
IntendedUse/Indicationsfor Use	The Getinge Assured MI SteamMigrating Integrator strip is an internalpack integrating indicator designed toreact to critical process parameters of asteam sterilization cycle within a statedtolerance. The integrating indicator isintended to be placed in each pack,pouch, tray, or container to function asan independent monitor of criticalparameters for the followingsterilization cycles:Steam Sterilization Cycles:250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes DynamicAir Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes DynamicAir Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes DynamicAir Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes DynamicAir Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity Stated values (as determined in asteam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C	The Getinge Assured MI Steam MigratingIntegrator strip is an internal packintegrating indicator designed to react tocritical process parameters of a steamsterilization cycle within a stated tolerance.The integrating indicator is intended to beplaced in each pack, pouch, tray, orcontainer to function as an independentmonitor of critical parameters for thefollowing sterilization cycles:Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic AirRemoval 270°F/132°C, 4 minutes Dynamic AirRemoval 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic AirRemoval 273°F/134°C, 4 minutes Dynamic AirRemoval 275°F/135°C, 3 minutes Dynamic AirRemoval 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic AirRemoval IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic AirRemoval IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS Stated values (as determined in a steamresistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C	The Intended Use of proposedmodified device is the same. Thissubmission proposes themonitoring of additional exposuretemperatures and times: 10 minutes at 132°CDynamic Air Removal 3 minutes at 134°C DynamicAir Removal 4 minutes at 134°C DynamicAir Removal
Device Design	A paper wick and a steam sensitivechemical pellet containing blue coloreddye. A pellet is held within a pocketlocated at one end of an aluminum foiltape base. The foil tape base is adheredto a film material that has been bondedwith a paper label. During steamsterilization, the integrating indicatorpellet will melt and migrate into thePASS window when the specifiedcritical parameters of steam	A paper wick and a steam sensitivechemical pellet containing blue colored dye.A pellet is held within a pocket located atone end of an aluminum foil tape base. Thefoil tape base is adhered to a film materialthat has been bonded with a paper label.During steam sterilization, the integratingindicator pellet will melt and migrate intothe PASS window when the specifiedcritical parameters of steam sterilizationhave been met.	Same
	sterilization have been met.
Sterilizationmethods andcycles	Steam Sterilization Cycles:• 250°F/121°C, 30 minutes Gravity• 270°F/132°C, 4 minutes DynamicAir Removal• 270°F/132°C, 15 minutes Gravity• 275°F/135°C, 3 minutes DynamicAir Removal• 275°F/135°C, 10minutes GravitySteam Sterilization Cycles (IUSS):• 270°F/132°C, 4 minutes DynamicAir Removal• 270°F/132°C, 3 minutes Gravity• 270°F/132°C, 10 minutes Gravity• 275°F/135°C, 3 minutes DynamicAir Removal• 275°F/135°C, 3 minutes Gravity• 275°F/135°C, 10 minutes Gravity	Steam Sterilization Cycles:• 250°F/121°C, 30 minutes Gravity• 270°F/132°C, 10 minutes Dynamic AirRemoval• 270°F/132°C, 4 minutes Dynamic AirRemoval• 270°F/132°C, 15 minutes Gravity• 273°F/134°C, 3 minutes Dynamic AirRemoval• 273°F/134°C, 4 minutes Dynamic AirRemoval• 275°F/135°C, 3 minutes Dynamic AirRemoval• 275°F/135°C, 10 minutes GravitySteam Sterilization Cycles (IUSS):• 270°F/132°C, 4 minutes Dynamic AirRemoval IUSS• 270°F/132°C, 3 minutes Gravity IUSS• 270°F/132°C, 10 minutes Gravity IUSS• 275°F/135°C, 3 minutes Dynamic AirRemoval IUSS• 275°F/135°C, 3 minutes Gravity IUSS• 275°F/135°C, 10 minutes Gravity IUSS	Same with the addition of cycles:• 10 minutes at 132°CDynamic Air Removal• 3 minutes at 134°C DynamicAir Removal• 4 minutes at 134°C DynamicAir Removal
Indicator Agent	Proprietary	Proprietary	Same
EndpointSpecifications	The endpoint is determined bymigration of the steam sensitive pellet,carrying the blue dye, to an areamarked PASS on the indicator.Endpoint is reached at the stated value(SV) for each claimed temperature.Endpoint is not reached at the statedvalue - 15% time and/or 1°C.	The endpoint is determined by migration ofthe steam sensitive pellet, carrying the bluedye, to an area marked PASS on theindicator. Endpoint is reached at the statedvalue (SV) for each claimed temperature.Endpoint is not reached at the stated value -15% time and/or 1°C.	Same
Shelf Life	5 Years	5 Years	Same

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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795

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6. Non-Clinical Performance Testing

Performance testing was conducted to verify that the proposed Getinge Assured MI Steam Migrating Integrator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014.

The following table summarizes the performance testing that was completed, with acceptance criteria and results to demonstrate that the Getinge Assured MI Steam Migrating Integrator met the requirements of its pre-determined acceptance criteria in its claimed intended steam sterilization cycles.

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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795

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Performance Testing of 3manufactured lots ofIntegrator	Pre-Determined Acceptance Criteria	Results
Steam Resistometer (BIERvessel) Testing:(According to ANSI/AAMI/ISO11140-1:2014 Sterilization of healthcare products - Chemical indicators- Part 1: General requirements andPremarket Notification [510(k)]Submissions for ChemicalIndicators - Guidance for Industryand FDA Staff.)	Pass result at the stated value for eachtemperature claimed:- 30 Minutes at 121°C- 3.8 minutes at 132°C, 4.1 minutes at 132°C,4.0 minutes at 132°C- 2.1 minutes at 134°C, 2.2 minutes at 134°C,2.4 minutes at 134°C- 1.7 minutes at 135°C, 2.0 minutes at 135°C,1.8 minutes at 135°C,	PASS
	Failing Result at 15% less time of SV for eachtemperature claimed	PASS
	Failing Result at 1°C less for each temperatureclaimed	PASS
Hospital Steam SterilizerTesting:	100% samples passing under passing conditionsfor each cycle	PASS
(To demonstrate pass/fail resultsfrom an actual sterilization cycleused in a health care facilityaccording to Premarket Notification[510(k)] Submissions for ChemicalIndicators - Guidance for Industryand FDA Staff)	100% samples failing under failing conditions foreach cycle	PASS
Dry Heat Testing:(According to ANSI/AAMI/ISO11140-1:2014 Sterilization of healthcare products - Chemical indicators- Part 1: General requirements andPremarket Notification [510(k)]Submissions for ChemicalIndicators - Guidance for Industryand FDA Staff)	Failing result when exposed to dry heat alone for30 minutes (±1 minute) at 140°C (±2°C)	PASS
Side-by-side testing of thebiological indicator andintegrator in steamresistometer:(As specified in PremarketNotification [510(k)] Submissionsfor Chemical Indicators - Guidancefor Industry and FDA Staff)	The integrator does not reach its endpoint beforethe biological indicator is inactivated	PASS
Offset/Transference:(According to ANSI/AAMI/ISO11140-1:2014 Sterilization of healthcare products - Chemical indicators- Part 1: General requirements.)	The indicator agent shall not offset or bleed,penetrate the substrate to which it is applied, ormaterials in which it is in contact before, duringor after the sterilization cycles for which it isdesigned	PASS

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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795

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7. Conclusion:

Based on the results from the performance testing per the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140- 1:2014, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K200252), Class II Indicator, physical/chemical sterilization process (21 CFR 880.2800), JOJ.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).